Label: RU-21 HANGOVER RELIEF- aspirin, caffeine capsule
-
Contains inactivated NDC Code(s)
NDC Code(s): 73156-010-20 - Packager: RU-21
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated June 21, 2019
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- Active ingredients (In each capsule)
- Uses
-
Warnings
Reye’s syndrome: Children and teenagers who have or are recovering from chickenpox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness.
Allergy alert: Aspirin may cause a severe allergic reaction, which may include: • hives • asthma (wheezing) • facial swelling • shock
Do not use
• if you have ever had an allergic reaction to aspirin or any other pain reliever/fever reducer
• in children under 12 years of age
Stomach bleeding warning:
This product contains a nonsteroidal anti-inflammatory drug (NSAID) which may cause severe stomach bleeding. The chance is higher if you:
• are age 60 or older
• have had stomach ulcers or bleeding problems
• take a blood thinning (anticoagulant) or steroid drug
• take other drugs containing prescription or non-prescription NSAIDs (aspirin, ibuprofen, naproxen, or others)• have 3 or more alcoholic drinks every day while using this product
• take more or for a longer time than directedAsk a doctor before use if
• stomach bleeding warning applies to you
• you have a history of stomach problems, such as heartburn • you have high blood pressure, heart disease, liver cirrhosis, or kidney disease• you are taking a diuretic
• you have asthma • you have a sodium-restricted dietStop use and ask a doctor if
• an allergic reaction occurs. Seek medical help right away.
• you experience any of the following signs of stomach bleeding: feel faint, vomit blood, have bloody or black stools, have stomach pain that does not get better
• pain lasts for more than 10 days or gets worse
• new symptoms occur
• redness or swelling is present
• ringing in the ears or a loss of hearing occurs
When using this product
• the recommended dose of this product contains caffeine. Limit the use of caffeine-containing medications, foods, or beverages because excess of caffeine may cause nervousness, irritability, irritability, sleeplessness, and occasionally rapid heartbeat.
• for occasional use only. Do not use for more than 2 days for a hangover unless directed by a doctor. Not intended for use as a substitute for sleep. If fatigue or drowsiness persists or continues to occur, consult a doctor.
Keep out of reach of children
In case of overdose, get medical help or contact a Poison Control Center right away.
-
Directions
upon waking, take 2 capsules with 8-12 oz. of water do not exceed recommended dosage
Adults and children 12 years and over (up to 60 years of age): 2-3 capsules every 6 hours, as needed, or as directed by a doctor. Do not exceed 8 capsules in 24 hours
Adults 60 years and over: 2 tablets every 6 hours, as needed, or as directed by a doctor. Do not exceed 4capsules in 24 hours Children under 12 years: Do not use - Other information
- Inactive ingredients
- Questions or Comments?
- Package Labeling:
-
INGREDIENTS AND APPEARANCE
RU-21 HANGOVER RELIEF
aspirin, caffeine capsuleProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:73156-010 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN 250 mg CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE 50 mg Inactive Ingredients Ingredient Name Strength SODIUM SUCCINATE HEXAHYDRATE (UNII: U16QOD6C4E) GELATIN (UNII: 2G86QN327L) MAGNESIUM STEARATE (UNII: 70097M6I30) Product Characteristics Color white Score no score Shape OVAL Size 18mm Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:73156-010-20 1 in 1 BOX 07/01/2019 1 20 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part343 07/01/2019 Labeler - RU-21 (093475272)
